A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)

Официальное название

A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants

Обзор

Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine. The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.

Вмешательства

• Препарат MK-4082
  Oral administration
• Препарат Diltiazem
  Oral administration
• Препарат Rescue medication
  All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.

Первичные конечные точки

• Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]
• Part 1: Maximum Plasma Concentration (Cmax) of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]
• Part 1: Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 31 days]
• Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 17 days]

Вторичные конечные точки (6)

• Part 2: AUC0-∞ of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]
• Part 2: AUC0-24 of MK-4082 [Срок оценки: At designated timepoints (up to 24 hours postdose)]
• Part 2: Cmax of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]
• Part 2: Time to maximum plasma concentration (Tmax) of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]
• Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082 [Срок оценки: 24 hours postdose]
• Part 2: Apparent terminal half-life (t½) of MK-4082 [Срок оценки: At designated timepoints (up to approximately 1 week postdose)]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Is in good health
• Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
• Had a recent pancreatitis or has a history of pancreatitis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Anaheim Clinical Trials ( Site 0001) — Anaheim

Идентификаторы

NCT: NCT07697625 · 4082-005 · MK-4082-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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